In the News

The FDA approved a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least 1 therapy before. The approval was granted under the FDA’s accelerated approval process to expedite access by patients with CLL to this promising new medication.
Transparent and comprehensive reporting of adverse events (AEs) in published results of oncology-related clinical trials is crucial for the treatment of patients with cancer.
Chronic obstructive pulmonary disease (COPD) is a common, life-threatening disease characterized by a persistent blockage of airflow from the lungs. COPD encompasses a range of chronic obstructive lung diseases, including chronic bronchitis and emphysema.
Diabetes affects an estimated 25.8 million people in the United States—a staggering 8.3% of the population. In addition, 35% of US adults have prediabetes and are at high risk for developing diabetes. Coinciding with the aging of the US population, the prevalence of diabetes is projected to increase dramatically over the next few dec­ades, from approximately 1 of 10 adults today to approximately 1 of 3 adults by 2050. Approximately 90% to 95% of all cases of diabetes are type 2 diabetes mellitus, and approximately 5% are type 1 diabetes mellitus.
Diabetes affects an estimated 25.8 million people in the United States—a staggering 8.3% of the population. Type 2 diabetes accounts for 90% to 95% of all adult cases of diabetes. In addition, an estimated 35% of US adults aged ≥20 years have prediabetes, and the prevalence of prediabetes jumps to 50% in adults aged ≥65 years.
Cutaneous melanoma, although not the most common skin cancer, is the most deadly. Based on data collected between 2003 and 2009, the 5-year survival rate for Americans with metastatic melanoma remains very low—only 16%—for all disease stages and for both sexes. The National Cancer Institute has estimated that approximately 1 in 49 people will be diagnosed with melanoma in the United States, and more than 9450 people will die of this disease in 2013.

On May 29, 2013, the US Food and Drug Administration (FDA) approved 2 targeted oral therapies for patients with melanoma. The 2 therapies were both developed by Glaxo­SmithKline and are targeting similar, but not the same, populations of patients with melanoma and a BRAF mutation. Both drugs were approved concurrently with the FDA approval of a companion diagnostic assay THxID BRAF (manufactured by bioMérieux) for the detection of BRAF V600E and BRAF V600K mutations.

On June 5, 2013, the US Food and Drug Administration (FDA) approved lenalidomide capsules (Revlimid; Celgene Cor­poration) for the treatment of patients with mantle-cell lymphoma whose disease has relapsed or progressed after 2 previous therapies, one of which included bortezomib (Velcade).

Glaucoma affects an estimated 2.2 million people in the United States, and is estimated to affect as many as 3 million people by 2020.1 Its prevalence is projected to rise with the aging of the US population.2 Glaucoma has the potential to destroy retinal ganglion cells in the optic nerve, which can lead to severe vision loss and blindness.1 In fact, glaucoma is a leading cause of blindness in the United States, accounting for 9% to 12% of all cases of blindness.3

Systemic juvenile idiopathic arthritis (SJIA) is a rare inflammatory disease, affecting approximately 10% of children diagnosed with juvenile idiopathic arthritis in the United States.1,2 The classic symptoms of SJIA include pain in the small joints of the hands, wrists, knees, and ankles; rash; and a high, spiking fever of ≥103°F that can last for weeks to months.3 By definition, SJIA can pre­sent at any point until the age of 16 years.

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